Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes (TRACK-D)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00786136 |
Recruitment Status :
Completed
First Posted : November 6, 2008
Last Update Posted : April 10, 2013
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced acute kidney injury (CIAKI). Major risk factors for CIAKI include older age, diabetes mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs, hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning that in a patient with CKD it amplifies the risk of CIAKI.
The aim of this multicenter prospective, randomized, controlled study is to evaluate whether statins treatment during the perioperative period would reduce the risk of CIAKI in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography or noncoronary angiography, and evaluate the influence of such potential benefit on short-term outcome.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus Chronic Kidney Disease | Drug: rosuvastatin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2998 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Multicenter Randomized Controlled Study of Rosuvastatin for Prevention of Contrast Induced Acute Kidney Injury in Patients With Diabetes and Slight to Moderate Renal Insufficient |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | November 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
perioperative rosuvastatin administration for at least 5 dosages
|
Drug: rosuvastatin
rosuvastatin |
Placebo Comparator: control
blank control of perioperative statin administration
|
Drug: rosuvastatin
rosuvastatin |
- An absolute increase in SCr >=0.5mg/dL(>=44.2μmmol/L)or a >= 25% increase in SCr from baseline to 72h after the procedure [ Time Frame: 72 h ]
- The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes. [ Time Frame: 30 d ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Planned diagnostic coronary or peripheral artery angiography
- T2DM
- CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2
- Statin naive, or not on statin treatment for at least 14 days
- Withdrawal metformin or aminophylline for 48h before angiography
- Total iodixanol volume
Exclusion Criteria:
- Hypersensitivity to iodine-containing compounds and statins
- Type 1 diabetes mellitus
- Ketoacidosis
- Lactic acidosis
- CKD stages 1,4 or 5 (eGFR≥90ml/min per 1.73m2 or eGFR<30ml/min per 1.73m2)
- STEMI
- NYHA class IV or hemodynamic instability
- Administration of any iodinated CM within 14 days before randomization
- LDL-C<1.82mmol/L(70mg/dL)
- Hepatic dysfunction (ALT 3 times greater than upper normal limit)
- Thyreoid insufficiency
- renal artery Stenosis(unilateral >70% or bilateral stenosis>50%)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00786136

Principal Investigator: | Yaling Han, MD | Shenyang Northern Hospital |
Responsible Party: | Han Yaling, MD, vice president, Shenyang Northern Hospital |
ClinicalTrials.gov Identifier: | NCT00786136 |
Other Study ID Numbers: |
SYNH-20081028 |
First Posted: | November 6, 2008 Key Record Dates |
Last Update Posted: | April 10, 2013 |
Last Verified: | April 2013 |
diabetes mellitus chronic kidney disease contrast induced acute kidney injury angiography |
Kidney Diseases Renal Insufficiency, Chronic Acute Kidney Injury Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Urologic Diseases Renal Insufficiency |
Rosuvastatin Calcium Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |